Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Congress Strikes Deal on COVID-19 Response Funding
The good news: Congressional negotiators have cut a deal for $10 billion in additional funding for COVID-19 testing and vaccination in the US. The bipartisan package will enable the federal government to purchase more therapeutics, tests, vaccines, and other...
Castle Biosciences Set to Acquire AltheaDx
In a key deal announced this week, Castle Biosciences signed a definitive agreement to acquire commercial-stage molecular diagnostics company AltheaDx, which specializes in pharmacogenomics testing services focused on mental health. In a statement released April 4,...
Medicare Patients Can Now Get Free OTC COVID-19 Tests
Medicare patients can now get over-the-counter (OTC) COVID-19 tests free of charge, CMS announced on Monday. From now through the end of the public health emergency, individuals with Medicare Part B coverage, including those in Medicare Advantage plans, can get up...
Labs in Court Weekly Roundup
Of the enforcement actions announced last week involving laboratories and the health care industry, the majority of cases involved urine drug testing. More specifically, three cases relating to urine drug testing involved an illegal kickback scheme as well as...
Explanatory AI Benefits Doctors Diagnosing Fetal Heart Disease
Researchers from the RIKEN Center for Advanced Intelligence Project (AIP) and colleagues have tested AI-enhanced diagnosis of fetal congenital heart disease in a clinical setting. Both hospital residents and fellows made more accurate diagnoses when they used a...
Radiopharmaceutical Gets FDA Approval for Treatment of Prostate Cancer
Patients with metastatic castration-resistant prostate cancer now have a new treatment option with the U.S. Food and Drug Administration’s (FDA’s) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The radiopharmaceutical medication, from Novartis...
Global Aspiration & Biopsy Needles Market to See Strong Growth
According to a recent report, this market will see almost seven percent annual growth over the next five years, reaching US $1.29 billion in 2026.
Balwani Lawyers: Elizabeth Holmes Entirely to Blame for Theranos
"Elizabeth Holmes, not Sunny, founded Theranos and built Theranos." So spoke defense counsel Steve Cazares in his opening statement in the trial of Theranos co-founder Ramesh “Sunny” Balwani, which resumed earlier this week. Pointing the finger at the other partner...
FDA Releases Latest List of Authorized At-Home OTC COVID-19 Tests
With coverage of over-the-counter (OTC) COVID-19 tests set to expand to include those covered by Medicare, the U.S. Food and Drug Administration (FDA) recently released its most up-to-date list of authorized at-home test kits for the SARS-CoV-2 virus that causes...
What’s New with G2? Brand Update and Q&A Session
Get an update on G2 Intelligence, learn what key lab industry stories our editors are following, and ask any questions you may have.